OR WAIT null SECS
How the UK is making progress in this hi-tech field.
Pharmaceutical 3D printing research has developed rapidly in the past five years; these days, numerous papers describing the development of novel 3D printable formulations using different drugs, excipients, and designs are published each month. The UK has been making particular headway in pushing this research forward. For example, FabRx, a spin-out from University College London (UCL), is the first company to focus on bringing 3D printing technology to the clinical setting. Last month, researchers from the University of East Anglia (UAE) announced they had identified a new method for the 3D printing of medicine in highly porous structures, with promising implications for the future manufacture of personalized medicine.
FabRx carries out lab and clinical research, developing pharmaceutical 3D printers and new formulations to be printed in hospital and pharmacy settings for printlets (i.e., 3D printed tablets) personalized to the patient. The company developed the first pharmaceutical 3D printer, M3DIMAKER™, which incorporates multiple 3D printing technologies to allow for versatility in formulating personalized medicines, including fused deposition modeling, semi-solid extrusion and direct powder extrusion. The company also led the first (and so far only) clinical trial for 3D printed personalized medicines in 2019, which focused on the treatment of maple syrup urine disease for pediatric patients in Spain. The trial’s printlets had changeable features, including drug dose, color, and flavor (with orange being the children’s favorite).
So far, the most commonly used 3D printing methods require a drug to be processed into spaghetti-like filaments prior to printing. But according to Sheng Qi, PhD, a reader in pharmaceutics at UEA’s School of Pharmacy, who led UEA’s research team, these pre-prepared filaments, made from hot-melt extruded drug-polymer formulations, do not work well with many pharmaceutical excipients used for oral solid dosage form products. The formulation has to be complex and the drug experiences thermal processing twice, which increases the risk of thermally induced drug degradation. The UAE team’s study involved a new thermoplastic printing technology that uses pellets or granules of drug-polymer mix and eliminates the need for filament making. By changing the size of the pores, the speed of a drug escaping from the tablet into the body can be regulated. Qi told Pharm Exec that this technology “will allow the printing on demand of solid dosage forms for patients with tailored dose and drug combinations to their individual clinical needs. This can happen at the point of care or a local printing hub, which can provide a cheaper treatment that can reach the patients faster.”
Barriers and future outlook
Currently, in the UK, there is no regulation for pharmaceutical 3D printing in clinical practice. Qi adds that there is a need for a new supply chain model to support point-of-care manufacturing of personalized medicine using 3D printing. Another barrier, says Alvaro Goyanes, PhD, FabRx’s co-founder and director of development, is “target users not accepting new technology.” But, he says, “this is a common problem across many fields,” adding that FabRx is approaching this problem by providing training and educational material for healthcare institutions worldwide. Both FabRx and the UAE researchers are also communicating with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to help guide future regulatory approval and clinical acceptance of pharmaceutical 3D printing technology.
UEA’s research now requires further work on how the porosity of 3D printed medicine can be used tailor the dose and dosing frequency to each patient’s needs and to build multiple medicines into a single daily poly-pill for patients who are on a complex medicine regiment.
Moving forward, Qi believes this technology could be widely in use in five to seven years. FabRx’s Goyanes hopes to see pharmaceutical 3D printers in clinical settings around the world within the next 10 years. “This may only be for a handful of drug formulations and treatment pathways because of the clinical trials required, but we will continue to help push development in this area for new patient groups.”
Julian Upton is Pharm Exec’s European and Online Editor. He can be reached at firstname.lastname@example.org.